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CDC Whistleblower Says Test Misses Too Many Zika Cases; US Special Counsel Calls For Review

The US CDC-promoted Trioplex Zika virus test that won an FDA emergency-use authorization in March is nearly 40% less sensitive than a rival CDC Zika test called Singleplex, a CDC microbiologist whistleblower told superiors in April. A review of his complaints by HHS and CDC did not substantiate that, and CDC demoted him. The US Special Counsel sent a letter to the White House this week asking for further review.

Policy Medical Device In Vitro Diagnostics

US FDA Approves First 'Artificial Pancreas' In Medtronic's MiniMed 670G

The hybrid closed-loop automated insulin delivery system, the first closed-loop system approved anywhere in the world, automatically monitors glucose and provides appropriate basal insulin doses in people with type 1 diabetes.

Approvals Diabetic Care Research and Development

Global Device-Makers Want India To Harmonize Standards

US medtech trade group AdvaMed is prodding the Indian government to harmonize what analysts have called “archaic” regulations governing medical devices with international standards, saying the result would be a win-win for both domestic and foreign companies.

India Regulation Market Access

Device Week – September 26, 2016

On this week's podcast, we discuss wound-care firm Advanced Medical Solutions, the latest developments for the US National Evaluation System for health Technology, and the debate over laboratory-development test regulations.

Medical Device United States United Kingdom
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More EU Audits, Post-Market Requirements: Tweeted Takeaways From ABHI Meeting

As the countdown to the EU Medical Device Regulation continues, delegates at the Association of British Healthcare Industries regulatory conference in London explored what to expect from the new rules. Here are some initial takeaways, tweeted by Medtech Insight from the meeting.

Europe Policy and Regulation Medical Device

Coordinating Antibiotics, Test Development Could Shorten Approval Times, US FDA Says

In a new draft guidance, the agency recommends antimicrobial drug developers and sponsors of antimicrobial susceptibility tests coordinate their regulatory submissions to get their products on the market together faster.

Policy and Regulation Diagnostics Medical Device

Latest From Policy and Regulation

Short-Term US Funding Bill Passes With $1.1bn In Emergency Zika Funds

Congress managed to settle its disputes over funding riders Sept. 28 and passed a relatively clean bill that contains $1.1bn in emergency Zika virus response funding, and will keep government agencies – including US FDA – running at current spending levels until Dec. 9.

United States Policy and Regulation

UK Regulator Wants To See Medtech Legislation It Shaped Appropriately Implemented

Implementing the Medical Device Regulations in the EU is going to be a massive challenge. The UK’s head of devices stresses the need for collaboration, increased manpower and solutions around notified bodies.

Europe Policy and Regulation

UK MHRA Presses For Leading Global Role Post-Brexit

The UK MHRA believes it has a valid and vital role to play on the global regulatory stage even after the UK leaves the EU.

United Kingdom Brexit

EU Regulation Recap: Chapter V Demonstrates Conformity Assessment Routes For Each Risk Class

What procedures will manufacturers need to follow to comply with the future medical device and IVD regulations, and when will a notified body need to be involved? A look at these issues as addressed in the fifth chapter of the pending regulatory documents.

Europe Policy and Regulation

Eurasian Medtech System Expects More Progress This Fall

More building blocks of the Eurasian Economic Union’s common medical technology regulatory system are falling into place – but are developments taking place fast enough for an early 2017 launch?

Russian Federation Kazakhstan

More EU Clinical Data Requirements Coming With New Regulations

In the EU, a two-step strengthening of requirements for clinical data means manufacturers and notified bodies need to act now, well ahead of the new Medical Device Regulations taking effect. Sarah Sorrel, president of device clinical research organization Medpass International, explains how and why in this guest column.

Medical Device Europe

Commercial

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Reapplix Seals In More Funding For Diabetic Foot Ulcer Patch

Reapplix, an emerging autologous cell-based wound therapy specialist, has secured additional funding that will take the company through the next year before it gets “market-ready” to launch its diabetic foot ulcer treatment in the US and EU.

Diabetic Care Wound Management Financing

Latest From Commercial

Sunshine Heart Changes Course Again: Pauses Neuromodulation To Focus On Aquadex

The company has switched from pursuing a counterpulsation technology to focusing on a fully implantable neuromodulation device, and is now directing its full attention to the recently acquired Aquadex FlexFlow ultrafiltration system for heart failure, all in a period of about three-to-four months.

Research and Development Clinical Trials

Intuitive Surgical, Fosun Pair Up For Lung Cancer JV

Intuitive Surgical is setting up a China-based joint venture with its distribution partner Fosun Pharma that will develop robotic-assisted, catheter-based devices for diagnosing and treating lung cancer.

Cancer Surgery

KO’d By Allergy Failure, Circassia Looks To Respiratory Pipeline For Second Wind

Circassia is shifting its focus on its respiratory portfolio following the disappointing Phase III results of its cat allergy drug in June, which saw the company’s share price plummet by more than 60%.

Respiratory Companies

Boston Scientific Buys EndoChoice, Mulls De-FUSEing Potential Weakness

Boston Scientific is making a significant investment in its endoscopy portfolio as it strikes a $210m deal to buy colonoscopy specialist EndoChoice. The Natick, Massachusetts, group added that it will be “evaluating strategic options” for EndoChoice’s Fuse colonoscope.

Gastroenterology M and A

Five Charged In $20m Embezzlement At Hearing Aid Company

Three former executives at hearing aid company Starkey Laboratories, along with two outside conspirators, are facing federal fraud, conspiracy and money-laundering charges. The defendants reportedly stole more than $20m via a complicated web of sham companies between 2006 and 2015.

United States Commercial

GE Will Back Start-Ups Shooting For Improved Global Health

GE Healthcare has launched a health-care accelerator program to support global-health start-ups aiming to improve health-care quality and accessibility in developing economies.

StartUps and SMEs Financing

Clinical R&D

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Glaukos' Micro-Bypass Stents Work As First-Line Glaucoma Therapy

Results of a 101-patient randomized clinical trial show that implantation of two iStent Trabecular Micro-Bypass stents is a viable initial treatment option, comparable to topical ocular hypotensive medications, in patients with newly diagnosed primary open-angle glaucoma.

Clinical Trials Research and Development Ophthalmology

Latest From Research and Development

Sunshine Heart Changes Course Again: Pauses Neuromodulation To Focus On Aquadex

The company has switched from pursuing a counterpulsation technology to focusing on a fully implantable neuromodulation device, and is now directing its full attention to the recently acquired Aquadex FlexFlow ultrafiltration system for heart failure, all in a period of about three-to-four months.

Research and Development Clinical Trials

Abbott Gains US Approval For Pro Version Of Flash Glucose System

The FreeStyle Libre Pro is intended to provide health-care providers with an easy-to-read visual summary of a diabetic patient's glucose data. Abbott has also filed for approval with FDA for a consumer-targeted version of the device.

Research and Development Innovation

FDA Greenlights Historical Control In Trial Of Regentis' GelrinC Knee Repair Material

The pivotal clinical study will support a US pre-market approval to allow Regentis Biomaterials to market GelrinC for the repair of focal knee cartilage defects in the knee, the largest unmet need in orthopedic sports medicine, according to the company.

Orthopedics Clinical Trials

Medtronic Neurosurgery Software Gains US FDA Clearance

The application helps surgeons effectively place deep brain stimulation leads during cranial surgery.

Research and Development Medical Device

Medtronic Artificial Pancreas Trial Results Published

Medtronic’s Hybrid closed-loop system is safe and improves some key patient outcomes, according to results published in the Journal of the American Medical Association. The system is currently before FDA for review.

Research and Development Medical Device

FDA Issues How-To On Computational Modeling Reports

The document, which finalizes a 2014 draft guidance, details 15 key areas device-makers should include in device-submission reports on computer modeling and simulation.

United States Research and Development
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